UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021626 |
|---|---|
| Receipt number | R000024943 |
| Scientific Title | Effects of olfactory stimulation derived from foods on mood and body temperatures: a randomized cross-over trial. |
| Date of disclosure of the study information | 2016/03/26 |
| Last modified on | 2019/03/08 16:55:06 |
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Basic information
Public title
Effects of olfactory stimulation derived from foods on mood and body temperatures: a randomized cross-over trial.
Acronym
Effects of olfactory stimulation derived from foods on mood and body temperatures.
Scientific Title
Effects of olfactory stimulation derived from foods on mood and body temperatures: a randomized cross-over trial.
Scientific Title:Acronym
Effects of olfactory stimulation derived from foods on mood and body temperatures.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes in mood and body temperatures after olfactory stimulation with foods in young women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Awakening/sleepiness scores
- resting condition
- during olfactory stimulation
- immediately after stimulation
Key secondary outcomes
Body temperatures
Warm sensation
Autonomic nervous system activities
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Olfactory stimulation using liquid with normal concentration -> Wash out -> Control (olfactory stimulation using mineral water)
- single administration
- 10 ml of sample
- 65-min stimulation
Interventions/Control_2
Control (olfactory stimulation using mineral water) -> Wash out -> Olfactory stimulation using liquid with normal concentration
- single administration
- 10 ml of sample
- 65-min stimulation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
1) Japanese women
2) Age >=20 years, <25 years
3)Good health conditions determined by the health examination in April 2015
4) Less than 2 kg body weight change within the past one month
5) Having a regular menstrual cycles
6) Informed consent provided
Key exclusion criteria
1) Pregnancy, breast-feeding, or planning a pregnancy
2) Received the medical treatment for hypertension/diabetes/dyslipidemia/heart disease or gastric ulcer
3) During medication
4) Had the excessive fatigue or stress within one month
5) History of smoking
6) Difficulty to determine the smell due to otolaryngology diseases
7) No alcohol tolerance
8) Subjects judged by the project leader to be ineligible for other reasons
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Narumi Nagai |
Organization
University of Hyogo
Division name
School of Human Science and Environment
Zip code
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan
TEL
+81-79-292-1515
nagai@shse.u-hyogo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Narumi Nagai |
Organization
University of Hyogo
Division name
School of Human Science and Environment
Zip code
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan
TEL
+81-79-292-1515
Homepage URL
nagai@shse.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
Suntory Grobal innovation Center Ltd. (the sample supplier)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Suntory Grobal innovation Center Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
兵庫県立大学環境人間学部（兵庫県）（School of Human Science and Environment, University ofHhyogo, Hyogo-prefecture)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jsnfs/71/5/71_243/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jsnfs/71/5/71_243/_article/-char/ja
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024943
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
